12616BR

Title:

Inspector Sr, In-Process & Finished Product, QC

Job Description:

Proficient in performing all duties and responsibilities of Inspector I and II, In-Process & Finished Product, QC, assist the QC Lead in reviewing device history record to assure compliance, and assist in training other QC Inspectors. Perform quality inspection functions during the development and validation phases of new products/projects. Perform quality control inspections on products at various stages of production from sub-assemblies to final assemblies to assure quality and conformance to specifications and procedural requirements. Job duties:

• Conduct visual/dimensional QC inspection and/or testing of incoming materials, in-process materials, sub-assemblies, labeling, and final inspection of finished goods while utilizing visual inspection systems and other inspection tools per inspection requirements to ensure conformance to Quality Specification and procedural requirements.

• Accurately measure and record data on data collection forms.

• Read and understand Product Drawings and specification dimensions.

• Input data into online tracking software.

• Provide feedback to Quality and/or Manufacturing on quality issues.

• Record, maintain, and communicate all nonconformance to relevant parties involved to ensure timely Corrective Action completion.

• Coordinate with production associates to perform in-process, finished product, and final documentation reviews to release finished goods.

• Maintain a safe and clean working environment following 5S principles.

• Assist with the validation inspection of new product development and/or product changes.

• Assist in training other QC Inspectors on QSs, TMs, and procedures.

• Consistently review in-process batch documentation to ensure real-time compliance with product specifications, Good Documentation Practices, SOPs, and cGMPs.

• Coordinate calibration of equipment/tools as required and maintain calibration records.

• Assist QC Lead in reviewing, closing, scanning, and uploading Build Records into the network drive.

• Assist QC Lead in sending out daily email reports.

• Discuss errors directly with line associates so corrections can be made if required.

• Must be able to work overtime when needed.

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

• Perform additional duties, including special projects, as assigned.

Auto req ID:

12616BR

Location:

Aliso Viejo, California, USA

Department Name:

311-Product Inspection Quality Assurance

Qualifications:

1. High school diploma or equivalent.

2. Minimum five (5) years of relevant experience in quality control for medical device manufacturing.

3. Previous experience with video inspection equipment and other inspection tools.

4. Experience with inspection sampling plans.

5. Strong reading, verbal, and written communication skills.

Desired Qualifications

1. Demonstrated knowledge of inspection techniques; understanding and reading technical documentation including product drawings.

2. Interpersonal savvy, able to clearly and effectively communicate (read, write, and speak in English).

3. Detail oriented

4. Knowledge of cGMP, GDP, QMS, and/or ISO regulations.

5. Knowledge of basic measuring techniques including scales, rulers, calipers, micrometers, etc.

6. Knowledge of computer software, including Windchill, Yield+, BR tracker, Documentation Error tracker, MS Word, Excel, Outlook, Teams, etc.

7. Ability to work in a fast-paced environment and to balance and prioritize workload to support production’s schedule.

8. Ability to work with a culturally diverse work population.

External-Facing Title:

Inspector Sr, In-Process & Finished Product, QC

Posting Country:

US - United States

Salary Range:

$22.01/hr. - $24.00/hr. (Compensation could be lower or higher based on education, experience and skill sets)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.